How to list or register a complementary medicine in Australia

White paper: How to list or register a complementary medicine in Australia

Vitamins, nutritional supplements, herbs, minerals, homoeopathic, aromatherapy preparations and other medicinal products with specific active ingredients are considered to be complementary medicines in Australia. This white paper discusses the actions you must take if you are seeking to supply or sell a complementary medicine in Australia.

This document was prepared in February 2016, any content including links and quoted regulation may be out of date. Please refer to the appropriate source for the most recent information. We endeavour to keep an up-to-date record of information at .

?2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited. MKT_TMP200_01_r06

PharmOut white paper: How to list or register a complementary medicine in Australia

Is your product a complementary medicine or not?

In Australia, complementary medicines include vitamin, mineral, herbal, aromatherapy and homoeopathic products. These products are often supplied by practitioners of traditional or alternative medicines. Products that may be considered to be food supplements or nutritional supplements in other countries are deemed to be complementary medicines in Australia. Multi-vitamin tablets are one such example. If your product meets one or more of the following criteria then it is possibly a complementary medicine and may be subject to regulation by the Therapeutic Goods Administration (TGA).

1. The product includes any of the following ingredients1: an amino acid charcoal a choline salt an essential oil plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll a homeopathic preparation a microorganism, whole or extracted, except a vaccine a mineral including a mineral salt and a naturally occurring mineral a mucopolysaccharide non human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates a lipid, including an essential fatty acid or phospholipid a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis a sugar, polysaccharide or carbohydrate a vitamin or provitamin

2. If the product shape or dosage looks like a medicine e.g. the product is in the form of tablets or capsules.

3. You are claiming that the product can prevent or treat a disease or has health benefits, i.e. a therapeutic claim.

1 Check the .au website for the current list of designated active ingredients for complementary medicines as they can change [].

PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151. Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@ Web:

?2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

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PharmOut white paper: How to list or register a complementary medicine in Australia

If your product does not meet one of these criteria then it is likely not considered a complementary medicine and will not be regulated by the TGA under the framework for complementary medicines.

How are complementary medicines regulated in Australia?

There are three classes of medicines in Australia, based on the health risk they represent to the person taking them. The three classes (from low risk to high risk) are:

Food - which includes food supplements

Listed medicines ? which includes most complementary medicines. This class is for lower risk products

Registered medicines ? these higher risk products include some complementary products, over the counter (OTC) medicines or prescription medicines2.

Your medicine may fall under either the `listed' or `registered' category, depending on the ingredients and the claims you are making about what the product does.

The first step is to determine if all of the active ingredients (those ingredients that have the effect on the health of the person using the medicine) in your product are already on the TGA's list of low-risk ingredients. Search the TGA website for `Substances that can be used in listed medicines" to find the current list. If all of the active ingredients in your product are on the list and you are using them in the way they have been approved for e.g. for topical use only or under a certain concentration, then your product fits into the TGA's `Listed' medicine category. Refer to the next section of this document for the next steps.

If your product contains ingredients that are not on the TGA's "Substances that can be used in listed medicines" list then getting your product approved for supply in Australia is a much more complicated and expensive process. You will need professional help to have your ingredients reviewed and added to the approved list by the TGA. That process is not covered in this white paper, however there are many other PharmOut White Papers, available on that may assist you.

2 Please refer to the separate PharmOut white paper on how to register products in this class

PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151. Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@ Web:

?2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

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PharmOut white paper: How to list or register a complementary medicine in Australia

My product is a listed complementary medicine, now what?

In essence, only an Australian legal entity i.e. person or company, can supply or sell a medicine in Australia. You can get an Australian company, or person to act as your local `sponsor' for this purpose. They are the ones whom the TGA will deal with in regards to your product. The sponsor can also appoint an `agent' to act on their behalf. An agent would normally be experienced and knowledgeable about dealing with the TGA. The different roles are defined below.

If your product is manufactured in a manufacturing facility that has: A TGA manufacturing licence (Australian manufacturers only), or A certificate (international manufacturers), or an overseas clearance

then the process of getting the product "listed" by the TGA is easy (refer to "Getting a manufacturing facility authorised by the TGA" later in this document).

If your product is manufactured in a manufacturing facility that does do NOT have a TGA manufacturing authorisation then you will need to submit information to the TGA to begin the process of getting the facility licenced. Refer to "Getting a manufacturing facility authorised by the TGA" later in this document.

If you intend to sell complementary medicines into Australia there are four roles that the TGA requires you to have in place. A single person/company can fulfil one or more role. If you have different companies in each role then there needs to be appropriate technical, quality and /or commercial agreements in place defining who is responsible for what.

The roles are:

Sponsor

This is the person or corporation who: exports, or arranges the export of the complementary medicines from Australia; or imports, or arranges the importation of the complementary medicines into Australia; or in Australia, manufactures complementary medicines or arranges for another person to manufacture them for supply.

Foreign manufacturers often appoint domestic sponsors in Australia to act on their behalf. The Sponsor is legally accountable for the product quality on the Australian market.

PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151. Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@ Web:

?2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

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PharmOut white paper: How to list or register a complementary medicine in Australia

Manufacturer This is the person, corporation or organisation in Australia or elsewhere who:

produces complementary medicines; or engages in any part of the process of producing the medicines or bringing the

medicines to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for sale of the medicines or of any component or ingredient of the medicines as part of that process. Only products that are manufactured in facilities that have been TGA-approved are allowed to be imported and distributed in Australia.

Agent This is any consultant, corporation or other organisation or person who is appointed by the Sponsor or Australian Manufacturer to represent them in consultations with TGA. The Agent cannot be a member of the particular sponsor/manufacturer client. Agent does not mean a sponsor who is the `Australian Agent'/distributor of an overseas manufacturer.

Distributor This is the person, corporation or organisation in Australia that will be responsible for the sale and distribution of the product. The overall GMP and legal responsibility of all the above parties will be discussed later. All legal responsibilities must be clearly defined and documented.

Getting a manufacturing facility authorised by the TGA

As discussed above, only products that are manufactured in facilities that have been TGAauthorised are allowed into Australia. Note that the TGA treats manufacturing facilities differently, depending on where they are located:

Domestic Manufacturers - If the facility is located in Australia then the TGA issues a Manufacturing Licence

International Manufacturers - If the facility is located outside of Australia then o the TGA inspects the manufacturer and, if acceptable, issues a Manufacturing Certificate, or o the manufacturer can go through the Overseas Clearance process, which is the cheapest and quickest method.

In all instances the manufacturing facility must first comply with the TGA's current Good Manufacturing Practices (cGMP) requirements before a TGA approval application is made for the product.

PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151. Ph: +61 3 9887 6412, Fax: +61 3 8610 0169, Email: info@ Web:

?2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

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